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Home > "I" Clinical Trials Conditions > Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis  Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
For Condition: leptomeningeal metastases
Status: Recruiting
Sponsor(s): Baylor College of Medicine ,
Synopsis: RATIONALE: Giving gemcitabineintrathecally may be an effective treatment for neoplastic meningitis. PURPOSE: Phase I trial to study the effectiveness of intrathecal gemcitabine in treating patients who have cancer and neoplastic meningitis.
Details: OBJECTIVES: - Determine the maximum tolerated dose and recommended phase II dose of intrathecal gemcitabine in patients with neoplastic meningitis. - Determine the qualitative and quantitative toxicity of this drug in these patients. - Determine the plasma and CSF pharmacokinetics of this drug in these patients. - Determine the response in patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. - Cohort 1: Patients receive gemcitabine intrathecally (IT) once weekly on weeks 1-6. - Cohort 2: Patients receive gemcitabine IT twice weekly on weeks 1-6. - Dose levels 2-6: Patients receive gemcitabine as in cohort 2 of dose level 1. All patients with stable or responding disease receive gemcitabine IT once weekly on weeks 7-12, every other week on weeks 13-28, and then every 4 weeks on weeks 29-52. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed monthly for 3 months and then every 3-4 months for up to 1 year. PROJECTED ACCRUAL: A total of 25-30 patients will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of neoplastic meningitis secondary to an underlying cancer - Primary leukemia or lymphoma in second or greater relapse - Refractory to conventional therapy, including radiotherapy - CSF cell count greater than 5/mm^3 AND evidence of blast cells on cytospin preparation or by cytology - Primary solid tumor - Presence of tumor cells on cytospin preparation or cytology OR presence of meningeal disease on MRI scan - No concurrent bone marrow relapse with leukemia or lymphoma - No evidence of obstructive hydrocephalus or compartmentalization of CSF flow as documented by radioisotope flow study - No impending spinal cord compression, CNS involvement (e.g., optic nerve) requiring local radiotherapy, or isolated bulky ventricular or leptomeningeal lesions PATIENT CHARACTERISTICS: Age: - 3 and over Performance status: - Karnofsky 50-100% (over 10 years) - Lansky 50-100% (10 years and under) Life expectancy: - At least 6 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 40,000/mm^3 (transfusions allowed) Hepatic: - Bilirubin less than 2.0 mg/dL - SGPT less than 2.5 times upper limit of normal (ULN) Renal: - Creatinine less than 2 times ULN - No clinically significant abnormalities of serum electrolytes, including calcium, magnesium, and phosphorus Other: - No other uncontrolled significant systemic illness - No uncontrolled infection except HIV - No ventriculoperitoneal or ventriculoatrial shunt unless shunt is nonfunctional and patient is shunt-independent - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy Chemotherapy: - Recovered from prior chemotherapy - Concurrent chemotherapy for systemic disease or bulk CNS disease allowed if not a phase I agent, an agent that significantly penetrates the CSF (e.g., high-dose methotrexate, thiotepa, high-dose cytarabine, fluorouracil, IV mercaptopurine, nitrosoureas, temozolomide, or topotecan), or agents with serious unpredictable CNS side effects Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior craniospinal irradiation and recovered - Recovered from prior radiotherapy - No concurrent CNS radiotherapy Surgery: - Not specified Other: - At least 1 week since prior intrathecal therapy - At least 2 weeks since prior investigational agents - At least 3 weeks since prior systemic CNS-directed therapy - No other concurrent systemic or intrathecal therapy for leptomeningeal disease - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanBlaney, Study Chair, Baylor College of Medicine
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15213-1863
United States
Recruiting Merrill Egorin 412-623-3252
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Lisa Bomgaars 832-824-4588
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Additional Information:
Study ID Numbers: CDR0000069356; BCM-63667,NCI-V02-1700,BCM-H10564
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039143
Other Leptomeningeal Metastases Studies:
1. Temozolomide in Treating Patients With Leptomeningeal Metastases From a Solid Tumor or Lymphoma
2. Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
3. Mafosfamide in Treating Patients With Progressive or Refractory Meningeal Tumors
4. Gemcitabine in Treating Neoplastic Meningitis in Patients With Leukemia, Lymphoma, or Solid Tumors
5. Intrathecal Busulfan in Treating Patients With Recurrent, Refractory, or Metastatic Leptomeningeal Tumors
Related Studies:
Other leptomeningeal metastases Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Intrathecal Gemcitabine in Treating Patients With Cancer and Neoplastic Meningitis
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